Understanding the Differences and Effectively Transitioning between the US Integrated Summaries of Effectiveness and Safety (ISE/ISS) and the CTD Summaries of Clinical Efficacy and... von Schwartz, David N., Umen, Michael J., Nomides, Kathy, Vanderhoof, Mary

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Preparing Regulatory Submissions with the FDA Reviewer in Mind: Use of the Clinical Review Template and Clinical Safety Reviewer Guidance by Sponsors von Vanderhoof, Mary, Umen, Michael J., Schwartz, David N.

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Chemistry of carbanions. XXVII. Convenient precursor for the generation of lithium organocuprates von House, Herbert O, Chu, Chia-Yeh, Wilkins, Joyce M, Umen, Michael J

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Six Enduring Principles for Preparing NDAS von Umen, Michael J.

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Reactions involving electron transfer. III. Conjugate addition of lithium dimethylcuprate to .alpha.,.beta.-unsaturated carbonyl compounds von House, Herbert O, Umen, Michael J

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New synthetic calcium selective ionophores. Design, synthesis, and transport properties von Umen, Michael J, Scarpa, A

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Empirical rules for estimating the reduction potential of .alpha.,.beta.-unsaturated carbonyl compounds von House, Herbert O, Huber, Larry E, Umen, Michael J

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Chemistry of carbanions. XXIV. Comparison of stereochemistry in alkylation and the Michael reaction von House, Herbert O, Umen, Michael J

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Chemistry of carbanions. XXV. Reaction of various organocopper reagents with .alpha.,.beta.-unsaturated carbonyl compounds von House, Herbert O, Umen, Michael J

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Complexation of calcium by the synthetic ionophore McN-4308, [2-(4-(diphenylmethy)-1-piperidinyl)-2-oxoethoxy]acetic acid. Crystal and molecular structure of the free acid and of t... von Van Roey, Patrick, Smith, G. David, Duax, William L, Umen, Michael J, Maryanoff, Bruce E

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Chemistry of carbanions. XXI. Stereochemistry of enolate alkylation in the 1-decalone system von House, Herbert O, Umen, Michael J

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Six enduring principles for preparing NDAs: Special Issue on Regulatory Affairs von UMEN, Michael J

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NEW SYNTHETIC CALCIUM-SELECTIVE IONOPHORES von Umen, Michael J., Scarpa, A.

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IP for drug document systems von Piper, Donald R, Umen, Michael J

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Drug document production system von Umen, Michael J, Nomides, Kathy J, Wilson, Phillip C, Martin, Erik A

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(2-AMINO-2-OXOETHOXY) ACETIC ACID COMPOUNDS, COMPOSITIONS AND METHODS von UMEN, MICHAEL J

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4-Substituted 3,5-morpholinediones von UMEN, MICHAEL J

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(2-Amino-2-oxoethoxy)acetic acid compounds von UMEN, MICHAEL J

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(Piperidino oxoethoxy)acetic acid compounds, compositions and methods von UMEN, MICHAEL J

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(2-Amino-2-oxoethoxy)acetic acid compounds, compositions and methods von UMEN, MICHAEL J

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